AccessGUDID - DEVICE: OsteoGen Strip (00855286006112)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoGen Strip
Version or Model: OSL20403
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Impladent, Ltd.

Primary DI Number: 00855286006112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 199838400 *Terms of Use

Device Description: OsteoGen Strips. OsteoGen bone graft combined with a bovine achilles tendon carrier

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46543	Composite bone graft	An implantable device that combines various bone substitute materials and/or bone growth factors to serve as a structural bone replacement typically when bone is lost due to trauma or osteoporosis. It is available in a variety of combinations such as collagen/ceramic, or polytetrafluoroethylene (PTFE) with carbon fibres.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPM	Bone Grafting Material, Animal Source

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090794	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73bdca7f-526c-40ce-be4e-1ca137da16b8
Public Version Date: August 30, 2023
Public Version Number: 1
DI Record Publish Date: August 22, 2023